MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; LARYNGEAL MASK, SZ 4, FLEXIBLE, DISP

Catalog Number	DYND300040S
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, the anesthesia team reported that the balloon is not staying inflated leading to "several" incidents where the tube required reinsertion.
Additional Manufacturer Narrative
According to the customer, the anesthesia team reported that the balloon is not staying inflated leading to "several" incidents where the tube required reinsertion.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to d9, h3, h6.After further investigation, it has been determined that a sample was returned and evaluated by the manufacturer on 1/13/26.The investigation involved testing of the actual/suspected device, trend analysis, and analysis of production records.Since no air bubbles were observed during evaluation of the returned samples, a device problem was neither found nor detected.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: LARYNGEAL MASK, SZ 4, FLEXIBLE, DISP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23919526
• Report Number: 1417592-2025-00755
• Device Sequence Number: 9030029
• Product Code: CAE
• UDI-Device Identifier: 10888277699526
• UDI-Public: 10888277699526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND300040S
• Device Lot Number: 59225072358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown